Intermittently wholly indwelling, user-actuated, continually-retained, valved urinary catheter

ABSTRACT

Problems associated with prostate enlargement can be negated by using the present valved catheter. Such can be inserted and removed by the user. The catheter is retained in place by a flexible, foldable tee bar attached to the valve plug, which in turn is attached to a stretchy Nylon line. To actuate the valve, the plug can be pulled out of the upper catheter simply by pulling on the distal end of the catheter, allowing urine to drain. When the user has an erection, the penis engulfs the entire valved catheter. That helps to assure that reproductive functions will not be affected.

This is a division [continuation] of utility patent application No. 12/455,485, filed Jun. 3, 2009. Such prior application was named: “WHOLLY INDWELLING, VALVE-ACTUATED, URINARY CATHETER—to counter benign prostate enlargement without surgery.” The present application is the result of on-going product development work that began with the idea behind the above referenced patent application. It is desired that the present application include the collective, unique art that will be embodied in the first commercial introduction of the product. Therefore, this application will describe the total invention as presently developed. Any unique feature or features of the present application—which a prudent observer would consider could easily be anticipated from the earlier patent application, should allow the present patent application to have the benefit of the earlier filing date for each such feature or features.

BACKGROUND OF THE INVENTION

Prostate enlargement, with the resulting restriction of urine flow, is a health issue that will affect a large majority of men as they age. Drugs; herbal therapy; stints; thermal or microwave tissue reduction; laser tissue removal; or surgical tissue removal are possible corrections for an enlarged prostate. So to is lifelong dependency on intermittent catheter use, for those not agreeable to, or suited for, the above treatments.

The present invention has as an objective being a more convenient, less costly and less dangerous correction of the symptoms of prostate enlargement compared to some of the treatments presently being tried. And it will correct such symptoms without severely interfering with a man's reproductive capacity, nor his sexual performance.

The present application, as well as the apt earlier patent application(s) by this inventor, have a user-actuated valve that will allow urine flow on demand. That is in contrast with having continuous-drip urine flow into a bag, as with a Foley catheter. The latter has a fluid-inflated bulb to retain such inside the bladder. The improvements inherent in the present invention relate in large measure to the means of retaining the valved catheter inside the bladder; the way in which the catheter is inserted and removed; and the location of the flow valve so as not to bruise or chafe the adjacent body tissues.

For the purpose of this patent application, it should be assumed that the suggested product construction materials will conform to, or surpass, the standards of health and safety recognized for products that remain in contact with body tissue. But it should also be noted that this invention isn't a surgical implant, but is a product that can be inserted and removed by the user, without expected difficulty nor complications.

BRIEF SUMMARY OF THE INVENTION

An enlarged prostate reduces the cross-section of the upper urethra. Any catheter that can pass through the prostate will allow a rate of urine flow that is proportional to the internal cross-section of the catheter, or to the cross-section of the opening(s) between that catheter and the bladder. The larger sizes will drain urine more quickly. But those also tend to be more difficult to insert, and more prone to bruise or abrade the urethra, or to irritate the meatus at the tip of the penis.

Catheters made of a rubber-like material have thicker walls than plastic catheters with the same internal cross-sectional area. Catheters need to be sufficiently stiff to allow such to be pushed through the urethra without buckling. The portion of the urethra just below the prostate has a fairly pronounced bend. That is where the most resistance is encountered to having a catheter be inserted. It is also a part of the urethra most easily bruised by a large and/or stiff catheter—such as while sitting, or in changing position.

The present invention will optimize the urine flow rate through the catheter tubing, while having a small enough overall diameter, and/or being flexible enough in consistency, so as not to physically injure the curved lower urethra; the curved prostate urethra portion; nor the bladder neck area.

The involuntary musculature of the bladder sphincter can dilate and expel objects the size of a typical glass marble. But inserting objects that size—and tubular objects in particular—up through the curved prostate urethra would normally be a medical process that requires anesthesia. Such fact negates using a fixed-size, enlarged-end retention device for a valved catheter. The present invention uses a flexible tee bar that is affixed to a thin but strong Nylon monofilament line which extends down the urinary catheter. The lower end of such line is stitched through the catheter wall, wound and knotted.

At the time of insertion, the flexible tee bar is folded upward at the top of the catheter, on axis with the catheter. It stays in that straight-up position during the insertion process, because it is tied with a second, temporary, monofilament line that is threaded through the catheter I. D. Once the flexible tee bar has been pushed into the bladder, as evidenced by the discharge of urine from the distal end of the catheter, the inserter simply pulls steadily on the latter monofilament line, causing the knot to come untied. Then, with no urethra walls to stabilize it, the flexible tee bar will spring back to its normal straight shape, preventing the valved catheter from falling out.

The lower tip of the catheter extends outside the flaccid penis. The valve, which is a modified ball or “plug” type, is kept in the normally closed position by the tension in the monofilament line, which functions similar to a tension or elongation spring. When the user desires to open the valve, as for voiding urine, he simply pulls down gently on the exposed end of the catheter. Doing the latter puts extra tension on the monofilament line, causing such to stretch longer. Because the force of the user's pull is being resisted by the flexible tee bar, the valve plug, which is attached to the center of the tee bar via a wire bail, is extracted from its place, opening the upper end of the catheter. As long as the user maintains gentle tension in the monofilament line, the valve will remain open. But the instant the user lets go of the lower end of the catheter, the tension in the monofilament line will yank the plug back into the top of such catheter, shutting off the outlet path.

The short, exposed portion of the lower catheter will be engulfed into the urethra when the user has an erection. That will allow having a normal sex life. Very importantly: The sperm and the seminal fluid will pass easily over the outside of the smooth catheter tubing. Since there has been no surgical cutting away of the upper prostate portions, there should be no retrograde ejaculations into the bladder. Once the penis returns to its flaccid state, the lower end of the catheter will again be exposed to view. That process will be facilitated by the normal, expulsive muscular contractions of the urethra.

Unlike a Foley catheter, that can have the inflated bulb become incrusted with particulate matter from the urine, the present invention has very little surface area that is in continuous contact with the urine. Even so, it would be advisable to remove the present valved catheter every four to six weeks. To do that, the user simply pulls downward slightly more strongly than in actuating the plug valve. That puts increased bending stress in the flexible tee bar tubing, causing such to double up—similar to the shape it had during insertion. Because the removal direction is downward, the tubing of the folded up tee bar will be restrained, laterally, by the walls of the urethra until the entire valved catheter assembly has been removed. The whole process should take no more than a minute. While the catheter is out, normal urination can be experimented with.

When the flexible tee bar tubing is in the folded up and tied position, two small, zee-shaped stainless steel tee-bar extension wires, which have been inserted therein from each side, will make the edge-to-edge, tied-together leading dimensions for the device only ⅛″× 1/16″ And the ⅛″ diameter of the flexible tee bar tubing, when folded up, will have a cross-section of 5/16″×⅛″—much smaller than the typical Foley catheter. Device component sizes that small will facilitate easy passage through the lower abdominal sphincter, the enlarged prostate, and the bladder outlet sphincter or neck. An antiseptic lubricating gel, concentrated in the area of the wires and the plug valve, will aid the insertion, as will a gentle, side-to-side twisting of catheter. Additionally and very importantly, the entire flexible catheter tubing will be ergonomically pre-curved to match the serpentine shape of a typical man's urethra. That pre-curve will greatly reduce the long-term bending stresses, over the length of the urethra, and make using the valved catheter more comfortable. Note: The latter consideration of user comfort has been lacking in much of the prior art of so many other inventors.

BRIEF DESCRIPTION OF THE VIEWS OF THE DRAWING

FIG. 1 indicates a schematic sectional view of the entire catheter relative to the anatomy of the user. The flexible tee bar is shown in elevation, though in actuality, that bar can rotate 360 degrees as determined by the bladder shape at the time.

FIG. 2 shows an enlarged sectional view of the closed upper catheter.

FIG. 3 shows a similar enlarged sectional view with the valve in the open position. Note: The monofilament line isn't required for valve actuation. Such is for closing the valve after the user pulls down on the catheter to stretch the line and thus open the valve.

FIG. 4 is an enlarged transverse section through the stainless steel valve-housing tube showing the large open area available for urine flow.

FIG. 5 is a schematic sectional view indicating how the flexible tee bar is tied together for insertion, and indicating the folded-up shape of such tee bar.

DETAILED DESCRIPTION OF THE INVENTION

Note: The following description explains the construction of the present catheter invention, and the relationship of its various parts. However, the following does not discuss the medical and physiological considerations of the design which have already been clearly explained in the Brief Summary of the Invention. Please refer to the latter in order to understand the objective functionality of the present catheter invention as a medical device.

Of primary consideration for devices inserted into the human body is having the components be compact enough not to cause discomfort during insertion or during utility. The present valved catheter places the compact valve of the catheter in the bladder neck, 2. A flexible catheter tube, 17, made of ether type polyurethane, extends through the urethra, 3, and the enlarged prostate, 1. The valve is a plug type. The tubular, hard plastic plug, 10, is made of PTFE and fits within the conical upper I. D., 16, of the flexible catheter tube, 17. To the latter is bonded a stainless steel valve-housing tube, 14, using free-lowing cyanoacrylate adhesive, 15. The tubular, hard plastic plug, 10, has a stainless steel wire bail, 8, extending through opposite sides. A monofilament line, 12, is looped around the lower ends of the stainless steel wire bail, 8, and the I. D. of the tubular, hard plastic valve plug, 10, is filled with gel type cyanoacrylate adhesive, 9.

A flexible tee bar tube, 6, made of ether type polyurethane, is fitted through the slightly smaller I. D. of upper stainless steel wire bail, 8, indenting the flexible tee bar tube, 6. The latter is held centered on the stainless steel wire bail, 8, by the insertion of two tee bar extension wires, 7, that are rounded on each end, both for easing the insertion into flexible tee bar tube, 6, and to present easily insertable leading edges when the flexible tee bar tube, 6, is folded upward to facilitate the insertion of the valved catheter. The tee bar extension wires, 7, force the 0. D. of the flexible tee bar tube, 6, to be larger than the I. D. of the stainless steel wire bail, 8, preventing the flexible tee bar tube, 6, from coming out from under the stainless steel wire bail, 8.

In FIG. 2 and FIG. 3, the side view of the stainless steel wire bail, 8, indicates that the width of such part exactly fits within the I. D. of the stainless steel valve-housing tube, 14, allowing such to guide the stainless steel wire bail, 8, in moving the tubular, hard plastic valve plug, 10, axially up and down. The latter precise motion will allow the rounded lower edge, 11, to be guided into the conical upper I. D., 16, of the flexible catheter tube, 17. FIG. 4 indicates the space between the 0. D. of the tubular, hard plastic valve plug, 10, and the I. D. of the stainless steel valve-housing tube, 14, has a large flow cross-section for urine into the flexible catheter tube, 17, once the rounded lower edge, 11, of the tubular, hard plastic valve plug, 10, has been pulled from the conical upper I. D., 16.

The monofilament line, 12, functions like a tension spring to hold the tubular, hard plastic valve plug, 10, and the attached flexible tee bar tube, 6, in place. A thin plastic sheath, 13, made of PEEK plastic, prevents the monofilament line, 12, from gripping into the walls of the flexible catheter tube, 17, but allows the slippage of the monofilament line, 12, as when the valve is actuated by pulling down on the distal end of flexible catheter tube, 17. The slightly stretched monofilament line, 12, is threaded through needle hole, 19, from inside to out, and is retained by a wrap and tie, 20. The flexible catheter tube, 17, has a rounded lower edge, 18, that is more comfortable for the user, as when the penis is in the erect state, 5, and when the penis is returning to the flaccid state, 4.

FIG. 5 shows a second monofilament line, 21, encased in a second plastic sheath, 22, made of PEEK plastic tubing. Such are used for untying the two half-hitch knot, 23, that keeps the flexible tee bar tube, 6, in the folded position, 24, during the insertion of the valved catheter. The untying of the two half-hitch knot, 23, is accomplished simply by pulling on the distal end of the monofilament line, 21, allowing the tee bar to spring out into the deployed position shown in FIG. 1. The high tensile strength plastic sheath, 22, can then be pulled out of the flexible catheter tube, 17.

The user can actuate the valve simply by pulling down, gently, on the exposed distal end of the flexible catheter tube, 17. That stretches the monofilament line, 12. Because the flexible tee bar tube, 6, is resisting the latter tug, said tube, 6, will slightly indent the bladder neck, 2. When the user desires to remove the valved catheter, he simply pulls down harder, until the flexible catheter tube, 17, folds up completely and the entire assembly comes out of the urethra, 3. 

1. A flexible plastic, valved catheter held in place within the bladder by a foldable, plastic tee bar tube that is attached through a stainless steel wire bail, which is attached to a rounded-end, rigid plastic tubing that constitutes the valve plug and which is glued and anchored to a stretchy monofilament line that keeps the valve plug seated within the conical shaped upper I. D. of the catheter until the user actuates the valve by pulling down on the distal end of the catheter, thus stretching the monofilament line, and yanking the valve plug out of the upper catheter I. D. so as to allow the discharge of urine from the bladder.
 2. A valved catheter, as in 1, above, that retains the foldable plastic tee bar tube in a centered relationship under the stainless steel wire bail by the insertion of two, short, zee-shaped and rounded end, stainless steel wires which force the O. D. of said tee bar tube to be greater than the I. D. of the stainless steel wire bail that is holding said tee bar.
 3. A valved catheter, as in 1, above, that is of sufficient length to protrude from the flaccid penis to allow easy valve actuation, but which will be engulfed into the urethra when the user has an erection, thereby allowing having normal sexual relations.
 4. A valved catheter, as in 1, above, that is ergonomically pre-curved into the shape of a typical man's urethra, to reduce the lateral bending stresses from the installed catheter that could be painful to the user.
 5. A means of temporarily tying the stainless steel wires of claim 2 together using monofilament line threaded through a thin-wall plastic sheath which can be untied after the valved catheter is past the bladder neck, simply by pulling on the monofilament line to release the knot, then removing the plastic sheath from within the flexible plastic catheter tube.
 6. A valved catheter as in 1, above, that has no obstructions to the flow of seminal fluids along the smooth outside of the flexible plastic catheter tube, as will facilitate normal insemination. 